Director, Protein Characterization

This is what you will do:  

This of Protein Characterization, which is part of the Analytical Development & Quality Control group which is one functional group of Product Development and Clinical Supply team, leads Alexion’s efforts to support new molecule manufacturability assessments and characterization of its biotherapeutics by physical and chemical means. This position will manage and oversee extensive product and impurity characterization and degradation pathway analysis for Alexion’s non-clinical, clinical and commercial stage products.  This position supports CMC by providing characterization summaries and comparability assessment/evaluation reports. This position leads the support efforts for Alexion’s Research, Cell Culture, Purification, Quality Control/Quality Assurance and Manufacturing with techniques available in protein characterizations, comparability, force degratiodation and CQA determination core facility.  

You will be responsible for:  

• Lead physicochemical characterization efforts for all stages of products  

• Establish phase-appropriate product degradation pathways for Alexion’s drug candidates 

• Design and execute product comparability assessment and comparability evaluation in a phase appropriate manner to support process changes  

• Design and execute product force degradation in a phase appropriate manner to support comparability and fulfill regulatory requirement.  

• Perform CQA assessment to ensure the desired product quality and support analytical control strategy  

• Lead product and impurity characterization for Alexion’s drug substance and drug product. Alexion’s product characterization laboratories are equipped with state-of-art instruments.  

• Provide characterization support to Research groups within Alexion 

• Provide reference standard characterization analysis for commercial or early stage products 

• Maintain appropriate compliance within area of responsibility with regards to current SOPs, instrument qualifications and training.  

• Represent the area functions as required during audits by agencies and internal/external auditors 

• Establish systems within area of responsibility to ensure compliance, good lab practices and work 

You will need to have: 

• Strong protein characterization skills are required demonstrated expertise in a wide range of protein analysis is required 

• Experience and expertise in complying with CMC requirements in product characterization is required 

• In depth understanding of protein degradation pathways is a must 

• In depth understanding of product comparability assessment and evaluation is required 

• Excellent written and verbal communication skills and demonstrated ability to work effectively in cross functional teams are required.  

• Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others.  

• Extensive experience in drafting and reviewing relevant CMC sections for regulatory filing is required. 

• Experience in corresponding with regulatory authorities is required 

• Ability to represent Alexion Pharmaceutical’s interests, objectives and policies in a responsible manner is required 

• Explore and assess new an